Date: 2017-02-13
Type of information: Completion of patient enrollment
phase: 3
Announcement: completion of patient enrollment
Company: Redhill Biopharma (Israel)
Product: Bekinda™(extended-release formulation of ondansetron)
Action
mechanism: antiemetic/5-HT3 antagonist. Bekinda™ is a proprietary, extended-release, once-daily oral pill formulation of the antiemetic drug ondansetron, targeting multiple gastrointestinal indications.
Disease: acute gastroenteritis
Therapeutic area: Inflammatory diseases - Gastrointestinal diseases
Country: USA
Trial
details: The GUARD study is a randomized, double-blind, placebo-controlled Phase III study is evaluating the safety and efficacy of Bekinda® 24mg in patients with acute gastroenteritis and gastritis. The primary endpoint for the GUARD study is the absence of vomiting or the need for rescue medications or intravenous hydration from 30 minutes through 24 hours after the first dose of the study drug. Secondary endpoints include, among others, frequency of vomiting, severity and time to resolution of nausea and time to resumption of normal activities.(NCT02246439)
Latest
news: * On February 13, 2017, RedHill Biopharma announced enrollment of last patient in Bekinda® phase III study for acute gastroenteritis and gastritis. The randomized, double-blind, placebo-controlled Phase III GUARD study with BEKINDA® 24 mg is conducted in 29 U.S. clinical sites and treated 320 adults and children over the age of 12 who suffered from acute gastroenteritis and gastritis. Top-line results are expected in the second quarter of 2017. In light of discussions with the FDA, RedHill believes that, subject to achieving highly significant positive results, the Phase III GUARD study may be sufficient as a single Phase III study to support potential future marketing application in the U.S., conditional upon, among other things, future review and guidance from the FDA. If approved, Bekinda® could become the first 5-HT3 antiemetic drug in the U.S. indicated for the treatment of acute gastroenteritis and gastritis, targeting a potential worldwide market estimated to exceed $650 million annually
Additionally, a phase 2 study with Bekinda® 12 mg is ongoing in the U.S. for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D), with top-line results expected in mid-2017.
